Duns Number:044606982
Device Description: Endopath Bipolar Active/Return Cord with Coaxial Pin Connector
Catalog Number
EBC02
Brand Name
ENDOPATH
Version/Model Number
EBC02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K904993,K904993,K904993
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
e2575ecc-3a18-4539-9589-8609231137b8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 15, 2016
Package DI Number
30705036004022
Quantity per Package
50
Contains DI Package
20705036004025
Package Discontinue Date
August 16, 2017
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 6 |